Active Patient Monitoring System
In a recent contact with FDA, senior managers admit FDA does not have a specific interpretation of boundaries that define Active patient monitoring. FDA tried to simplify the language by replacing the cumbersome phrase “real-time, active, or online patient monitoring” with simply “not intended to be used in connection with active patient monitoring”. The goal was to express more succinctly the passive role MDDS devices play in comparison to an active decision-making function.The following language from Compliance Consultants offered to seniors at FDA on 19 March 2015 as our interpretation of boundaries that define Active patient monitoring.
An Active Patient Monitoring system is defined as having a feedback mechanism to the control or delivery of a treatment or diagnosis. The feedback mechanism forms a contiguous control circuit. The feedback or contiguous control cannot be interrupted. The input from the patient is delivered to the device that processes data according to a decision making process (algorithm) which the device outputs back to affect patient care.
An active patient monitoring system must have a contiguous circuit where a physiological element transmits data from that element that results in an unbroken received message that is active in directing the continuation of the activity of the physiological element. A contiguous circuit can be composed of hardware and software but not a health care professional.
An Active Patient Monitoring system cannot by design have an included “disjointed or interrupted loop”.
A “disjointed or interrupted loop” is a function where humans intervene between the receipt of information and the reaction to the data delivered to dispense a remedy or diagnosis.
A “disjointed or interrupted loop” is also where the treatment or diagnosis affords time delays (regardless of the time interval- seconds or days).
A health care professional goes to the bathroom. That disrupts
a contiguous circuit (active patient monitoring)
Where a health care professional interrupts a contiguous
circuit such as being involved (prescription device)
in the delivery of a treatment or the review of a
diagnostic result that circuit is not contiguous
and is not an active patient monitoring system.
If any of these “disjointed or interrupted loops” occur in the design then that is not an active patient monitoring system.
The period of time of the “disjointed function” or “interruption of the loop” is inconsequential to the device being in the design category.
Also in consideration should be that an MDDS must be a secondary display to a regulated medical device and are not intended to provide primary diagnosis, treatment decisions.
If a Class I, MDDS device has a regulated medical device in front as a display or buffer that is the regulated host of the data, the MDDS can as a Class I device simply present or replicate the data without qualifying as a medical device.
As an example, if a physiological sensor (such as a Class II blood glucose monitor or an ECG monitor) detects, processes and constructs the patient data (the regulated medical device) then it can output that regulated, constructed data onto a MDDS display, MDDS printer, or MDDS Bluetooth device that can repeat or forward the information.
The Class II physiological sensor functions as a regulated device that constructs patient data and that data can be sent as simply graphic “dumb x,y coordinates” that can be presented by almost any secondary type data display (Class I ) device.
The Class II physiological sensor functions as a regulated device and is the primary regulated device and the Class I, MDDS device is the secondary display at some convenient occasion.
If any of these “disjointed or interrupted loops” occur in the design then that is not an active patient monitoring system.
The period of time of the “disjointed function” or “interruption of the loop” is inconsequential to the device being in the design category.
Also in consideration should be that an MDDS must be a secondary display to a regulated medical device and are not intended to provide primary diagnosis, treatment decisions.
If a Class I, MDDS device has a regulated medical device in front as a display or buffer that is the regulated host of the data, the MDDS can as a Class I device simply present or replicate the data without qualifying as a medical device.
As an example, if a physiological sensor (such as a Class II blood glucose monitor or an ECG monitor) detects, processes and constructs the patient data (the regulated medical device) then it can output that regulated, constructed data onto a MDDS display, MDDS printer, or MDDS Bluetooth device that can repeat or forward the information.
The Class II physiological sensor functions as a regulated device that constructs patient data and that data can be sent as simply graphic “dumb x,y coordinates” that can be presented by almost any secondary type data display (Class I ) device.
The Class II physiological sensor functions as a regulated device and is the primary regulated device and the Class I, MDDS device is the secondary display at some convenient occasion.
